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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

While FDA said it would prefer to see a "well-defined and reliable patient-reported outcomes (PRO) instruments that measure the clinically important signs and symptoms associated with each IBS subtype," such an endpoint does not yet exist, making clinical evaluation of treatments difficult.

Rather than wait for instruments capable of definitively measuring symptoms to be created, FDA said it was moving ahead to offer guidance in the face of "great need" for effective IBS therapies. The guidance notes PROs can be used as primary endpoints for clinical studies, and makes study design recommendations to take provisional PROs into account.

In the meantime, FDA said it is working with the Critical Path Institute (C-Path) and its own qualification process to develop instrumentation and other validated drug development tools. (DDTs)

The final guidance also makes a number of changes to draft guidance issued in March 2010, including the addition of a randomized withdrawal design, the clarification of trial endpoints intended to treat a single symptom of IBS, modified trial entry criteria from patients suffering from only IBS-D, and new definitions for several symptoms.